1. Field
The apparatus, system, and method described, illustrated, and claimed in this document relate generally to a mobile wireless communications instrument capable of implementing a medication management system. More specifically, the mobile wireless medication management system uses a protocol that may be stored in memory in a computer processor or data processor that is operatively connected to the mobile wireless communications instrument to implement the medication management requirements of the protocol. The use of the mobile wireless communications instrument in combination with the protocol allows a patient and a medication provider, to confirm use and/or ingestion by the patient of a correct medication prescription, at the correct time, in the correct dosages. A notification subsystem is included to either confirm or reject use of the medication.
2. Background
As the U.S. Food and Drug Administration warned in an article entitled “Medical Errors Can Be Deadly Serious,” the Institute of Medicine of the National Academy of Sciences reported that between 44,000 and 98,000 Americans die each year not from the medical conditions they sought help for, but from preventable medical errors. A “medical error” may include a health-care provider choosing an inappropriate method of care; or intending to infuse a patient with one medicine, but inadvertently giving the patient another medicine or a different dosage. As a result, such medical errors are the eighth leading cause of death among Americans. Indeed, medical errors exceed those from motor vehicle accidents (43,458), breast cancer (42,297), and A/DS (16,516). Patients in hospitals are only a small proportion of those at risk, according to studies made by the FDA, because doctor's offices, clinics, and outpatient surgical centers treat thousands of patients daily. In addition, retail pharmacies fill countless prescriptions. Nursing homes and other institutional venues serve a vulnerable patient population.
What the FDA report described as the seemingly simple process of giving a patient medicine—the right drug, in the right dose, to the right patient, at the right time—is, in reality, teeming with opportunities for error. Confusion and medication mismanagement often seem symbiotic.
The confusion arises from sound-alike names; from look-alike containers having look-alike labels patients rarely pause to read; and from a patient having the correct drug in the correct dosage, but selecting the incorrect medicine from among a variety of medicines the patient uses.
As of July 2005, one publication reported that the annual cost of drug-related morbidity and mortality was nearly $177 billion in the United States. Medication errors had occurred in about one of every five: doses given in hospitals. The report quoted the FDA in stating that there is at least one death per day, and 1.3 million people injured each year, due to medication mismanagement.
The problem of incorrect medication ingestion and use is not limited to the United States. Similar reports emanate from abroad. For example, a report from the United Kingdom in late 2004 indicated that drug prescription errors were a common cause of adverse incidents although largely preventable. A similar report was published in Australia.
Interest in the use of data processors and, by implication, mobile wireless communications instruments to help manage medication prescription and use, already is evident. But for the fear of loss of privacy and theft of the database, posting medical records of patients online for availability at least in event of emergency would be already a reality.
Based on a report entitled “Caremark: Clinical Up-Date,” from the office of the U.S. Inspector General, August 2001, annual costs to the health care industry of failure to provide the right medication in the right dosages at the right time is staggering. The estimates then of the cost included $100 billion to health care payers; 125,000 deaths per year due to heart attack and strokes; $30 billion lost sales to pharmaceutical companies; $8 billion in lost revenue for pharmacies; and add-on costs $31.3 billion, or 23% of all nursing home admissions for the additional costs associated with using bar codes and/or RFD tags.
It is apparent, therefore, that a medication management system not only is useful, but necessary. While the mobile wireless medication management system disclosed, illustrated, and claimed in this document could be enabled using a variety of devices and apparatus, use of a mobile wireless communications instrument as at least one of the preferred devices or apparatus is appropriate in view of the national and international exponential increase in use of mobile wireless communications instruments by people of all ages and genders. Many mobile wireless communications instruments now are adapted to create and transmit images across a mobile wireless communications system, a capability that assists in implementing the medication management system. Of course, use of a mobile wireless communications instrument is not a limitation of the invention of this document. The mobile wireless medication management system may be implemented using a variety of wireless and non-wireless apparatus and devices.
Alternatives to the present invention have been suggested. One alternative is generally referred to as an RFID system. Radio-frequency identification (“RFID)” is an automatic identification method relying on storing and remotely retrieving data using devices called RFID tags or transponders. An RFID tag can be attached to or incorporated into a product, animal, or person for purpose of identification using radio waves. All RFID tags contain at least two parts, an integrated circuit for storing and processing information, modulating and demodulating a radio frequency (“RF”) signal, and perhaps other specialized functions; and an antenna for receiving and transmitting the signal.
Because medicines, including pills and fluids, are often required to be strictly accounted for, the use of RFID in the medical field has been explored. However, RFID is a comparatively expensive solution to medication management problems. Another limitation is the read distance range of some forms of RFID tags, which may be only four inches. Another limitation of RFD)'s is the need for an external antenna significantly larger than the chip in the best version thus far developed. The cost of implementing an RFID program, however, remains the principle limitation.
Recently the U.S. Food and Drug Administration issued a ruling that essentially begins a final review process that will determine whether hospitals may use RFID systems to identify patients and/or permit relevant hospital staff to access medical records. Since then, a number of U.S. hospitals have begun implanting patients with RFID tags and using RFID for inventory management. As will be evident to those skilled in the art, it is much less invasive to use the system for medicine management described, illustrated, and claimed in this document.
Another alternative to the present invention is use of barcodes. A barcode is machine-readable, using dark ink on a white substrate to create high and low reflectance converted to 1's and 0's representative of information in a visual format on a surface. Barcodes can be read either by optical scanners called barcode readers, or scanned from an image by special software. The use of barcodes, however, in a long-distance wireless communications environment is of questionable practicality.
Accordingly, at least one advantage provided by use of a mobile wireless communications instrument is the capability to electronically and digitally compile information that could be stored in the mobile wireless communications instrument comparable to printed versions of the Physicians' Desk Reference®. The Physicians' Desk Reference (“PDR”) is a commercially published compilation of manufacturers' prescribing information on prescription drugs, updated annually. While designed to provide physicians with full, legally mandated information relevant to writing prescriptions, the PDR has become widely available in libraries and bookstores. At least one advantage of an electronic and digital summary of such information would arise from the ability to update information substantially in real time, and to include additional information about medications and treatments of illness as discoveries and/or improvements are developed.
Another advantage provided by use of a mobile wireless communications instrument is the capability of storing on one or more mobile, and/or related mobile or non-mobile communications instruments, including data processors, computers, patient histories and/or patient health records (collectively, in this document, “patient history” or “patient histories”). Such chronological records of significant information relating to a patient's health, treatment, and medication use, and the names and contact information of medication providers, could be updated in substantially real time, and would be available for a review by a medication provider, even for a patient traveling outside the patient's country of residence. In addition, a patient history may also include potentially important information in the form of vital signs. The term “vital signs” as used in this document means at least a patient's pulse rate, respiratory rate, body temperature and ranges, blood pressure, weight, heart rate, and/or blood glucose level, among other vital signs.
There is a worldwide need, therefore, for an apparatus and method that provides and implements a medication management protocol that, in combination with the mobile wireless communications instrument, enables a patient and a medication provider to image-identify and image-authenticate (i) a patient, (ii) a medication provider, (iii) a medication, (iv) correct dosage of a medication for a patient, and (v) correct timing for ingestion or use of a medication by a patient.
A worldwide demand also exists for a system that provides system of medication management that may be used in combination with a mobile wireless communications instrument. As indicated above, mobile wireless communications instruments, including but not limited to mobile cellular telephones, are becoming more and more common worldwide. In addition, many of the mobile wireless communications instruments are equipped with image-making and image transmission features that contribute to implementing the system of medication management. The images may be, for example, in color, black-and-white, for both. Also, the checks and balances provided by the mobile wireless medication management system disclosed, illustrated, and claimed in this document may be transmitted substantially in real time across a wireless communications system to enhance the value of the mobile wireless medication management system.